- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02836327
Multimodel Magnetic Resonance Imaging (MRI)of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders
Multimodel MRI to Explore the Pathophysiology of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders
To investigate multimodel MRI exploring the pathophysiology of multiple sclerosis and neuromyelitis optica spectrum disorders.
The investigators use multimodel MRI to evaluate the extent of blood-brain barrier and white matter fiber tracts destruction , iron deposition and cerebral blood flow of associated regions in multiple sclerosis and neuromyelitis optica spectrum disorders using contrast-enhanced magnetic resonance imaging , quantitative susceptibility mapping, diffusion tension imaging, and arterial spin labeling with post labeling delay of 2.0 seconds. Transfer constant volume , magnetic susceptibility, cerebral blood flow and fractional anisotropy(FA) value were measured in lesion and normal appearing white matter.
Study Overview
Status
Intervention / Treatment
Detailed Description
Patients:
Patients with multiple sclerosis and neuromyelitis optica spectrum disorders were included. clinical characteristics such as disease duration, expanded disability status scale(EDSS) score, age, associated laboratory examination(autoantibodies directed to aquaporin-4 and oligoclonal bands in serum as well as cerebrospinal fluid)were recorded.
Imaging scan were conducted at admission, six months and one year after admission
Imaging protocols:
MRI scan protocols: T2 weighted image, T1 weighted image, Diffusion weighted image(DWI), fluid-attenuated inversion recovery(FLAIR), dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI) , diffusion tension imaging(DTI) ,quantitative susceptibility mapping(QSM) , arterial spin labeling(ASL) with post labeling delay(PLD) of seconds, sagittal CUBE Fluid Attenuation Inversion Recovery (FLAIR) images, sagittal 3-dimensional Fast Spoiled Gradient Echo(3D-FSPGR).
Contrast agent:
Omniscan 0.1mmol/kg, Inject rate:2ml/s
Imaging evaluation:
Transfer constant volume value measured by DCE-MRI indicates the extent of blood-brain barrier destruction.
Magnetic susceptibility manifests iron deposition in lesions and normal appearing white matter.
Diffusion tension imaging demonstrates the extent of white matter fiber tracts destruction.
Arterial spin labeling(ASL) with post labeling delay(PLD)of seconds shows cerebral blood flow in associated regions.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Xiaoxiao Ma, M.D.
- Phone Number: +86 13323326150
- Email: 1103483781@qq.com
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- a diagnosis of neuromyelitis optica spectrum disorders(according to the 2015 revised diagnostic criteria) or relapsing remitting multiple sclerosis(according to the 2010 revised Mcdonald criteria)
- age between 18 years old and 60 years old(concluding 18 years old and 60 years old)
Exclusion Criteria:
- common exclusion for MRI such as patients with claustrophobia
- patients with poor imaging quality(Poor imaging quality mainly defined as the image cannot be applied to future analysis on account of severe motion artifacts appeared in conventional MRI and mistakes in the MRI process by accident factors which cannot to be applied to future analysis)
- patients with taking amount of antidepressant recently and with alcoholism and other nervous system diseases
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Multiple sclerosis
Multiple sclerosis patients confirmed by neurologist according to the 2010 revised Mcdonald criteria without other nervous system diseases.All patients performed magnetic resonance imaging.
|
Magnetic Resonance Imaging
|
Neuromyelitis optica spectrum disorders
Neuromyelitis optica spectrum disorders confirmed by neurologist according to the 2015 revised diagnostic criteria without other nervous system diseases.All patients performed magnetic resonance imaging.
|
Magnetic Resonance Imaging
|
Health control
Health control is defined as no other nervous system diseases such as ischemic stroke, alzheimer disease and so on.
The baseline data(age,education background etc.) is similar to multiple sclerosis and neuromyelitis optica spectrum disorders patients.All participants performed magnetic resonance imaging.
|
Magnetic Resonance Imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence
Time Frame: three months to one year
|
The patients will be monitored whether they recured multiple sclerosis and neuromyelitis optica spectrum disorders confirmed by neurologist and conventional MRI. Clinical suspicious signs of recurrence : visual loss,urination and defecation function disturbance and so on. Conventional MRI: there are new lesions or the lesions show high signal on diffusion weighted images or enhancement on post contrast enhanced images. |
three months to one year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Myelitis, Transverse
- Optic Neuritis
- Multiple Sclerosis
- Sclerosis
- Disease
- Neuromyelitis Optica
Other Study ID Numbers
- MS and NMOSD-ChinaPLAGH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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